Application 217221

Type: ANDA
Sponsor: DIFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE	LIDOCAINE	PATCH;TOPICAL	1.8%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217221-001	LIDOCAINE	LIDOCAINE	1.8%	PATCH / TOPICAL	AB		2025-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A217221-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217221-001	LIDOCAINE	1.8%	PATCH / TOPICAL	AB	2025-03-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217221-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217221-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217221-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217221-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217221-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217221-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 26 · 514 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5523fdfe-69fd-49a5-b51f-73e2223d49a9	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Solis Pharmaceuticals Inc.	3061d301-2104-b1b2-e063-6394a90a9b6e	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	InterMed Laboratories Private Limited	33ed754e-8852-d5b2-e063-6394a90a7cf2	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	32b96689-8e9b-4c2e-e063-6294a90a7d1c	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3304e362-dcda-3f5e-e063-6294a90a7015	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2f2f753d-c791-e863-e063-6394a90aec5d	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3162c96a-061d-2971-e063-6394a90a9b74	2025-04-29	Warnings	Name fallback generic name: LIDOCAINE
Walgreens Lidocaine Knee and Elbow	LIDOCAINE	Walgreen Co.	a3fb4c78-1493-4ba4-ae83-502dd825ed67	2025-04-25	Warnings	Name fallback generic name: LIDOCAINE
Walgreens Lidocaine Back	LIDOCAINE	Walgreen Co.	e6bfd342-c0db-46b9-b5e6-5acbd860adf1	2025-04-25	Warnings	Name fallback generic name: LIDOCAINE
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Pharmheal	32e57c0f-d138-88dc-e063-6394a90ac085	2025-04-16	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE	Advanced Rx of Tennessee, LLC	325ddb61-84f5-075c-e063-6294a90ad5e9	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: Lidocaine generic name: LIDOCAINE
Numb 520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	984c4bee-0d44-4e0f-a057-0d54400c4cac	2025-04-02	Warnings	Name fallback generic name: LIDOCAINE
HemAway	LIDOCAINE	Melaleuca, Inc.	cf842adf-fcd7-2c8c-e053-2995a90adea6	2025-03-27	Warnings	Name fallback generic name: LIDOCAINE
Numb and Number Anorectal Cream	LIDOCAINE	Dermtech Labs, Inc	31420635-5021-173d-e063-6294a90a407a	2025-03-26	Warnings	Name fallback generic name: LIDOCAINE
Adellina Numbing Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	314a83fe-8bdb-766f-e063-6294a90a61c6	2025-03-26	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine	LIDOCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cddb2b22-fce3-8967-6e54-dca3df5ac4b3	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Lidocaine
Leader Maximum Strength Hemorrhoidal Relief	LIDOCAINE	Cardinal Health,Inc.	65c780b0-7f47-4ae9-a847-c22deaaa2888	2025-03-21	Warnings	Name fallback generic name: LIDOCAINE
Lidocaine 4%	LIDOCAINE	Innovida Pharmaeutique Corporation	eb83a3dd-557e-4334-b806-5fc05e9175a3	2025-03-19	Warnings	Name fallback generic name: LIDOCAINE
TheraCare Pain Relief 4% Lidocaine	LIDOCAINE	Veridian Healthcare	2d3fc030-5d53-2acd-e063-6294a90a11ab	2025-03-11	Warnings	Name fallback generic name: LIDOCAINE
Muscle and Joint Care	LIDOCAINE	Vege Labs LLC.	301966b5-b535-dc04-e063-6394a90aec17	2025-03-11	Warnings	Name fallback generic name: LIDOCAINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.